RESUMEN
BACKGROUND: Women with breast cancer experience different symptoms related to surgical or adjuvant therapy. Previous findings and theoretical models of mind-body interactions suggest that psychological wellbeing, i.e. levels of distress, influence the subjective evaluation of symptoms, which influences or determines functioning. The eight-week mindfulness-based stress reduction (MBSR) program significantly reduced anxiety and depression in breast cancer patients in a randomized controlled trial (NCT00990977). In this study we tested the effect of MBSR on the burden of breast cancer related somatic symptoms, distress, mindfulness and spiritual wellbeing and evaluated possible effect modification by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing. MATERIAL AND METHODS: A population-based sample of 336 women Danish women operated for breast cancer stages I-III were randomized to MBSR or usual care and were followed up for somatic symptoms, distress, mindfulness skills and spiritual wellbeing post-intervention and after six and 12 months. Effect was tested by general linear regression models post-intervention, and after six and 12 months follow-up and by mixed effects models for repeated measures of continuous outcomes. Effect size (Cohen's d) was calculated to explore clinical significance of effects among intervention group. Finally, modification of effect of MBSR on burden of somatic symptoms after 12 months' follow-up by adjuvant therapy and baseline levels of, distress, mindfulness and spiritual wellbeing were estimated. RESULTS: General linear regression showed a significant effect of MBSR on the burden of somatic symptoms post-intervention and after 6 months' follow-up. After 12 months' follow-up, no significant effect of MBSR on the burden of somatic symptoms was found in mixed effect models. A statistically significant effect of MBSR on distress was found at all time-points and in the mixed effect models. Significant effects on mindfulness were seen after six and 12 months and no significant effect was observed for spiritual wellbeing. No significant modification of MBSR effect on somatic symptom burden was identified. CONCLUSION: This first report from a randomized clinical trial on the long-term effect of MBSR finds an effect on somatic symptom burden related to breast cancer after six but not 12 months follow-up providing support for MBSR in this patient group.
Asunto(s)
Neoplasias de la Mama/psicología , Atención Plena/métodos , Espiritualidad , Estrés Psicológico/terapia , Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Quimioterapia Adyuvante , Dinamarca , Femenino , Estudios de Seguimiento , Humanos , Modelos Lineales , Persona de Mediana Edad , Radioterapia Adyuvante , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
BACKGROUND: There is evidence that both breast cancer patients and their partners are affected emotionally, when facing a breast cancer diagnosis. Several couple interventions have been evaluated, but there is a need for couple intervention studies with a clear theoretical basis and a strong design. The Hand in Hand intervention is designed to enhance interdependent coping in the couples and to address patients and partners that are both initially distressed and non-distressed. METHODS: The Hand in Hand study is a randomised controlled trial among 199 breast cancer patients and their partners. Couples were randomised to 4-8 couple sessions with a psychologist in addition to usual care, or to usual care only, approximately 2 months after the patients' primary surgery date. The intervention was delivered within 3 months, and outcomes were assessed prior to randomisation and 5 and 10 months after primary surgery date. The primary outcome is patients' cancer-specific distress at the 5-month follow-up measured by the Impact of Event Scale. Secondary outcomes are assessed for both breast cancer patients and partners. These outcomes are: general distress, symptoms of anxiety and depression, health-related quality of life and measures of dyadic adjustment, intimacy and partner involvement. Cancer-specific distress is also assessed for partners. Eligible patients were women ≥ 18 years newly diagnosed with primary breast cancer, cohabiting with a male partner, having no previous cancer diagnoses, receiving no neo-adjuvant treatment, having no history of hospitalisation due to psychosis, and able to read and speak Danish. Partners were eligible if they could read and speak Danish and were ≥ 18 years. DISCUSSION: This study investigates the effect of an attachment-oriented psychological intervention for breast cancer patients and their partners. The intervention has a theoretical framework and a strong design. If proven effective, this intervention would be helpful in optimising psychosocial care and rehabilitation of couples coping with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01368380.
RESUMEN
INTRODUCTION: As the incidence of and survival from breast cancer continue to raise, interventions to reduce anxiety and depression before, during and after treatment are needed. Previous studies have reported positive effects of a structured 8-week group mindfulness-based stress reduction program (MBSR) among patients with cancer and other conditions. PURPOSE: To test the effect of such a programme on anxiety and depression among women with breast cancer in a population-based randomised controlled study. METHODS: A total of 336 women who had been operated on for breast cancer (stage I-III) were randomised to usual care or MBSR+usual care. Questionnaires including the Symptom Checklist-90r anxiety and depression subscales and the Center for Epidemiological Studies-Depression scale were administered before randomisation and immediately, 6 and 12 months after the intervention. RESULTS: Intention-to-treat analyses showed differences between groups in levels of anxiety (p=0.0002) and depression (SCL-90r, p<0.0001; CES-D, p=0.0367) after 12 months. Graphical comparisons of participants with higher levels of anxiety and depression at baseline showed a significantly greater decrease in the intervention group throughout follow-up and no differences among least affected participants. Medium-to-large effects were found for all outcomes in the intervention group in analyses of change scores after 12 months' follow-up. CONCLUSION: The 8-week group based MBSR intervention had clinically meaningful, statistically significant effects on depression and anxiety after 12 months' follow-up, and medium-to-large effect sizes. Our findings support the dissemination of MBSR among women with breast cancer. (Clintrials.gov No.: NCT00990977).